GE Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance System
FDA device recall Z-0815-2007 · posted 2007-05-18 · Terminated
Recall details
- Recalling firm
- GE Medical Systems LLC
- Reason for recall
- To provide the 3.0T MRI systems users with the 8-channel brain coil the proper coil weighting software. The proper coil weighting factors for the eight-channel brain coil were not included in the software.
- Action taken
- The corrective action is already completed and all customers have been notified via a personal visit to each site, to install a software patch beginning June, 2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 30 units
- Distribution
- Worldwide, including USA, China, Finland, Germany, Israel, Italy, Korea, Spain, and Taiwan.
- Date initiated
- 2006-06-01
- Date posted
- 2007-05-18
- Date terminated
- 2008-02-24
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE SIGNA 3.0T WITH EXCITE MR SYSTEM (K040444) | General Electric Co. | 2004-04-14 |